Genetically Modified Mesenchymal Stem Cell Theraopeutic Against Head and Neck Cancer

NCT02079324 | Completed Phase 1

• 1 other identifier: GX-051_HNC_1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to evaluate MTD, Safety and efficacy of GX-051 after intratumoral injection in head and neck cancer patience.

Conditions

Head and Neck Cancer

Keywords

head and neck cancer; gene therapy; stem cell therapy; immunotherappy

Outcome Measures

Primary Outcomes (1)

• MTD after GX-051 intratumoral injection

  2 months

Secondary Outcomes (6)

• Adverse events after GX-051 intratumoral injection

  2 months

• Anti-tumor response by RECIST 1.1 on computed tomography

  2 months

• Changes of INF-γ and IL-12 levels in blood comparing to the baseline after GX-051 intratumoral injection

  2 months

• Changes of immune cell distribution in tumor tissue after GX-051 intratumoral injection

  2 months

• Evaluation of antibody generation against IL-12 which is active ingredient of GX-051

  2 months

Study Arms (1)

GX-051

EXPERIMENTAL

GX-051 intratumoral injection

Biological: GX-051

Interventions

GX-051 BIOLOGICAL

intratumoral injection

GX-051

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are capable of understanding and complying with the requirements of the study and have signed the informed consent from (ICF).
• Very advanced head and neck cancer aged more than 19.
• Longest distance of the tumor is bigger than 1 cm and capable of Intratumoral injection.
• Baseline ECOG Performance Status 0, 1 or 2.
• Have a life expectancy more than 6 months.

You may not qualify if:

• Have no history of prior anticancer treatment.
• Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.Subject who have participated in a clinical trial of an treatment vaccine or immunotherapy in an year.
• Have a tumor which is near a main vessel that can be occured embolism after injection or which has hypervascularity.
• Patients currently receiving anticancer immuno-therapies Patients who have received prior treatment with an stem cell therapy.
• Have autoimmune disease (multiple sclerosis, systemic lupus erythromatosis, thyroiditis, psoriasis, inflammatory bowel diseases etc.).
• Have Graft rejection reaction such as GVHD.
• Have immunodeficiency disease.
• Leukocytes\< 3.0 x109/L.
• Absolute neutrophil count \< 1.5x109/L.
• Platelet count \< 100 x 109/L.
• Have known positive test for hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV).
• Alanine Aminotransferase (ALT) \> 2.5xUNL.
• Aspartate Aminotransferase (AST)\> 2.5xUNL.
• Total Bilirubin\> UNL.
• Have blood Creatinine\> UNL.

Sponsors & Collaborators

• Genexine, Inc.: lead

Study Sites (1)

Seoul St.Mary's Hospital of the Catholic University of Korea

Seoul, 137-701, South Korea

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Minsik Kim, M.D.

  Seoul St.Mary's Hospital of the Catholic University of Korea

  PRINCIPAL INVESTIGATOR

• Hyun-Tak Jin, ph.D.

  Genexine, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: March 5, 2014
• Study Start: March 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: August 22, 2025

Record last verified: 2014-03

Locations

KR (1)